# K160925: VPS Rhythm Device with TipTracker Technology

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)
- Decided: Dec 22, 2016 after 262 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 7 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K001901 (2000). 35 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 40 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152261: PICC Tip Positioning Aid, Nostix, LLC (2015) Summary page 4.

## Most influential descendants
- K240486: PM2 System and ECGuide Connector (2024), 2 descendants of its own
- K252792: PM2™ System with ECGuide™ Connector (2025), 0 descendants of its own
- K243484: PM2+ System and SmartPICC Stylet (2025), 0 descendants of its own
- K220363: VPS Rhythm DLX Device with TipTracker Technology (2022), 0 descendants of its own

## Recalls of this device
- Aug 10, 2023 · Class I · Z-0004-2024: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- May 17, 2018 · Class II · Z-2383-2018: Product pouch label may not easily identify the lot number, expiration date and associated symbols..
- May 17, 2018 · Class II · Z-2384-2018: Product pouch label may not easily identify the lot number, expiration date and associated symbols..
- May 17, 2018 · Class II · Z-2382-2018: Product pouch label may not easily identify the lot number, expiration date and associated symbols..
- Apr 11, 2018 · Class II · Z-2028-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2026-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2027-2018: Product sterility may be compromised due to unsealed packaging.

## Indications for use
The VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient’s cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm Device, indicated for visual navigation of a peripherally-inserted central catheter (PICC) as it is inserted through the vasculature. The TipTracker technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement. Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including - Atrial fibrillation - Atrial flutter - Severe tachycardia - Pacemaker-driven rhythm - Chronic obstructive pulmonary disease (COPD) Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

Source page: https://510kreport.com/device/K160925
Methodology: https://510kreport.com/methodology